PRAVASTATIN TABLET
Država: Kanada
Jezik: angleščina
Source: Health Canada
Lastnosti izdelka
(SPC)
09-11-2020
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Aktivna sestavina:
PRAVASTATIN SODIUM
Dostopno od:
SANIS HEALTH INC
Koda artikla:
C10AA03
INN (mednarodno ime):
PRAVASTATIN
Odmerek:
40MG
Farmacevtska oblika:
TABLET
Sestava:
PRAVASTATIN SODIUM 40MG
Pot uporabe:
ORAL
Enote v paketu:
30/100
Tip zastaranja:
Prescription
Terapevtsko območje:
HMG-COA REDUCTASE INHIBITORS
Povzetek izdelek:
Active ingredient group (AIG) number: 0122563003; AHFS:
Status dovoljenje:
APPROVED
Datum dovoljenje:
2010-11-03
Lastnosti izdelka
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
PRAVASTATIN
Pravastatin Sodium Tablets
10 mg, 20 mg and 40 mg
Manufacturer’s Standard
Lipid Metabolism Regulator
Sanis Health Inc.
Date of Revision:
1 President’s Choice Circle
November 9, 2020
Brampton, Ontario
L6Y 5S5
SUBMISSION CONTROL NO.: 244865
_ _
2
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
............................................. 3
SUMMARY PRODUCT INFORMATION
................................................................... 3
INDICATIONS AND CLINICAL USE
.........................................................................
3
CONTRAINDICATIONS
..............................................................................................
5
WARNINGS AND PRECAUTIONS
.............................................................................
5
ADVERSE REACTIONS
.............................................................................................
11
DRUG INTERACTIONS
.............................................................................................
15
DOSAGE AND ADMINISTRATION
.........................................................................
17
OVERDOSAGE
...........................................................................................................
18
ACTION AND CLINICAL PHARMACOLOGY
....................................................... 19
STORAGE AND STABILITY
.....................................................................................
21
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................ 21
PART II: SCIENTIFIC INFORMATION
................................................................... 23
PHARMACEUTICAL INFORMATION
.....................................................................
23
CLINICAL TRIALS
.....................................................................................................
24
DETAILED PHARMACOLOGY
................................................................................
30
TOXICOLOGY
.............
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